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The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT03434067
Recruitment Status : Unknown
Verified September 2018 by Bo Wang,MD, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : February 15, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bo Wang,MD, Fujian Medical University

Study Description
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Brief Summary:
The half-life of the parathyroid hormone is about 4min, blood pth test is use in operation to confirm that parathyroid tumor is removed. but the blood pth test is time consuming and unpractical in most of hospital. this study will compare the application of rapid PTH test paper in operation of hyperparathyroidism.PTH test were measured in operation in different way. it will test at the time of preoperation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. thus evaluate the reliability and accuracy of PTH test paper in evaluating the Miami principles with the linear relation of blood PTH and the PTH test paper method.

Condition or disease
Hyperthyroidism Thyroidectomy PTH Immunochromatographic

Detailed Description:
Primary hyperparathyroidism is a clinically common disease. At present, the gold standard for determining whether the operation is successful is based on the Miami principle. That means The PTH hormone decreased to 30% of the baseline level after 15min after the tumor was removed. However, due to the differences in PTH monitoring conditions in various hospitals, many hospitals cannot perform rapid PTH monitoring in the operation. Therefore many doctors choose rapid freezing pathology to confirm the lesion., This also led to the inability to evaluate PTH in the presence of multiple lesions,and resulting in the need for reoperations.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 30, 2018
Groups and Cohorts
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Group/Cohort
Primary hyperthyroidism
Patients diagnosed with primary hyperparathyroidism are prepared for parathyroid surgery. PTH test paper is used addtional at the time point according to Miami principle
Secondary hyperthyroidism
Patients diagnosed with Secondary hyperthyroidism are prepared for parathyroid surgery. PTH test paper is used addtional at the time point according to Miami principle
Unilateral thyroidectomy
Patients diagnosed with unilateral thyroid benign tumor were prepared for unilateral thyroidectomy. PTH test paper is used addtional at postoperation
thyroidectomy and bilateral CCD
Patients diagnosed with bilateral thyroid carcinoma were prepared to undergo total thyroidectomy and bilateral central clearing.PTH test paper is used addtional at postoperation


Outcome Measures
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Primary Outcome Measures :
  1. Serum PTH [ Time Frame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation ]
    Routine serum PTH test, using immunoluminescence.

  2. Serum calcium [ Time Frame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation ]
    Routine serum electrolyte detection.

  3. PTH test paper [ Time Frame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation ]
    PTH test paper test for blood


Biospecimen Retention:   Samples Without DNA
In addition to the normal preoperative preparation of blood Biospecimen before admission, the PTH test paper was used to detection the PTH in remanent blood biospecimen .

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We use the characteristics of short half-life of the parathyroid hormone and try to evaluate it by PTH strip semi-quantitative method. PTH, blood calcium and PTH test were measured at pre-operation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. To evaluate the reliability and accuracy of PTH strip in evaluating the Miami principles with the linear relation of blood PTH and the test paper method.
Criteria

Inclusion Criteria:

  • Primary hyperthyroidism.
  • Secondary hyperthyroidism
  • Unilateral thyroidectomy.
  • Total thyroidectomy and bilateral central compartment dissection

Exclusion Criteria:

  • age Older than 70 or younger than 18.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434067


Contacts
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Contact: wenxin zhao, md 13365910359 zhaowx@fjmu.edu.cn
Contact: bo wang, md 13705947900 wangbo@fjmu.edu.cn

Locations
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China, Fujian
Wen-xin ZHAO Recruiting
Fuzhou, Fujian, China, 350001
Contact: Wen-xin ZHAO, MD    8613365910359    zhaowx@fjmu.edu.cn   
Contact: Bo WANG, MD    8613705947900    wangbo@fjmu.edu.cn   
Sponsors and Collaborators
Bo Wang,MD
Investigators
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Study Chair: wen-xin zhao, md Fujian Medical University Union Hospital
More Information
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Additional Information:

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Responsible Party: Bo Wang,MD, Clinical professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03434067    
Other Study ID Numbers: PTH test paper
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bo Wang,MD, Fujian Medical University:
hyperthyroidism
thyroidectomy
PTH
immunochromatographic assay
Additional relevant MeSH terms:
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Hyperparathyroidism
Hyperthyroidism
Parathyroid Diseases
Endocrine System Diseases
Thyroid Diseases